ELISIO-H AND ELISIO-M HEMODIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BIOSPAL 1200S

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

REXEED SERIES DIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AMICON HEMOCONCENTRATOR SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PrisMax System Version 2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HEMOCOR HP HEMOCONCENTRATOR SERIES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Tablo Hemodialysis System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Purema® H Hemoconcentrator (EtO Sterilized)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NxStage System One

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HEMOFILTRATION SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LUNDIA ALPHA 700 HEMODIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology